DAFNEplus cluster randomised controlled trial

Not Applicable

• Conditions: Type 1 diabetes; Nutritional, Metabolic, Endocrine; Type 1 diabetes mellitus

• Registration Number: ISRCTN42908016
• Lead Sponsor: Sheffield Teaching Hospital NHS Foundation Trust

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33462097/ protocol (added 02/02/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-17
• Last Update Posted: 18 July 2023
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 471

Inclusion Criteria

1. Adults (=18 years)
2. Diagnosis of type 1 diabetes for at least 6 months, or post-honeymoon
3. Prepared to undertake multiple daily injection (MDI) therapy and frequent self-monitoring of blood glucose
4. Confirms availability to attend all sessions as part of the intervention
5. Investigator has confidence that the patient is capable of adhering to all the trial protocol requirements

Exclusion Criteria

Current exclusion criteria as of 31/12/2019:
1. Current use of continuous subcutaneous insulin infusion (CSII) pump therapy
2. HbA1c > 12%/108 mmol/mol (Investigators can use their judgement, informed by standard DAFNE guidelines and in agreement with the trial team, to include participants with HbA1c >12%/108 mmol/mol)
3. Serious diabetic complications (e.g. blindness, renal dialysis). (Investigators can use their clinical judgement, informed by standard DAFNE guidelines and in agreement with the trial team).
4. Other serious co-morbidities e.g. psychosis, diagnosed eating disorder (Investigators can use their clinical judgement, informed by standard DAFNE guidelines and in agreement with the trial team).
5. Previous participation in standard DAFNE course less than 5 years before proposed study enrolment date
6. Unable to hear/speak/understand/read/write in English
7. Unable to give written informed consent

_____
Previous exclusion criteria:
1. Current use of continuous subcutaneous insulin infusion (CSII) pump therapy
2. HbA1c > 12%
3. Serious diabetes-related complications (e.g. blindness, renal dialysis), or other serious co-morbidities (e.g. psychosis, diagnosed eating disorder)
4. Previous participation in standard DAFNE course less than 5 years before proposed study enrolment date
5. Unable to hear/speak/understand/read/write in English
6. Unable to give written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified